Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients

January 27, 2017 updated by: Alexander Sah, MD, Washington Hospital Healthcare System

Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.

The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.

Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).

Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary joint replacement

Exclusion Criteria:

  • no prior joint surgery
  • no infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard suture
standard suture used (monocryl)
Device: standard suture
Active Comparator: Barbed suture
barbed suture used (Quill suture, Surgical Specialties)
Device: barbed suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of soft tissue infections
Time Frame: 12 weeks
evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination
12 weeks
use of antibiotics to treat infection, recorded by number
Time Frame: 12 weeks
record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded
12 weeks
measurement of incision drainage, measured in grams and mm surface area
Time Frame: 2 weeks
evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm
2 weeks
assessment of quality of incision closure, recorded by time and number
Time Frame: 12 weeks
record delayed healing and reported by time, suture rejection based on number of episodes
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington Hospital Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 8, 2017

First Submitted That Met QC Criteria

January 21, 2017

First Posted (Estimate)

January 25, 2017

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHHSIJRR001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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